Regulatory

Volcano Corporation a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced FDA clearance of its proprietary instant wave-Free Ratio™ or iFR® Modality.

Implantable lens manufacturer STAAR Surgical Company tells us that its Visian Toric Implantable Lens or TICL received favorable votes to three questions presented to the U.S. FDA’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee.

German ultrasound expert, eZono AG has received FDA 510(k) clearance for its eZono 4000 dedicated procedural guidance system with eZGuide technology, providing “any plane” freehand navigation.

Thoratec has issued updated information regarding the problems highlighted in its device correction letter of two weeks ago. It’s reinforcing the guidance that patients should visit their doctor for retraining on how to use the Heartmate II device in the light of new evidence that the process of changing from older controllers presents the highest risk of problems.

BioCardia®, Inc. has gained CE Mark approval for its Morph AccessPro™ Steerable Introducer, designed for easier navigation through the vasculature during delivery of biotherapeutics and medical devices.

Boston Scientific Corporation has announced CE Mark approval and European market launch of the INGEVITY™ family of magnetic resonance imaging (MRI) compatible pacing leads.

Boston Scientific Corporation has received CE Mark approval for the REBEL™ Platinum Chromium Coronary Stent System, the company’s latest generation … continue reading “CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary Stent”

Scottish vascular graft company Vascutek has announced the return to market of its Anaconda™ Bifurcate Body Stent Graft System. The system has been out of circulation since October 2013.

Pretty much a year after having gained the FDA’s nod for its Fortiva Porcine Dermis Patch, RTI Surgical Inc. has received CE mark approval for the product and says it will begin distribution throughout Europe.

A pioneer in orthopaedic 2D/3D imaging, EOS imaging has announced the CE mark of hipEOS, a 3D hip arthroplasty planning software based on EOS biplanar 3D imaging.

Ventripoint Diagnostics Ltd. has announced that the U.S. FDA has cleared the VMS™ heart analysis system to be an adjunct to all existing 2D ultrasound imaging devices to allow computation of the 3D volume and ejection fraction of the right heart in patients with Pulmonary Arterial Hypertension

CSI’s new Diamondback Peripheral 60cm systems are available in two crown designs, the 1.25mm Micro Crown, and the 1.25mm Solid Crown. Each device offers a shorter shaft length, a smaller profile and a more flexible shaft than their predecessors for improved ease of use.

The U.S. FDA has cleared Maxx Orthopaedics’ Freedom PCK Revision Knee System claimed by its manufacturer to be one of the most bone-conserving, low profile revision knee systems available on the market.

It’s AAOS week in New Orleans and less invasive joint restoration company Arthrosurface, Inc.has chosen the event to announce receipt of FDA Clearance for its new ToeMotion™ Total Toe Restoration System.

Quite a time for AngioDynamics. First the company gets news that another iteration of its successful BioFlo platform has gained FDA’s nod. Then, its distribution partner Medcomp gets the FDA’s knock-back over its 510(k) submission for the Celerity tip location system, leading AngioDynamics to take over the regulatory reigns there too.

Whether this is a milestone or not remains to be seen, but it just might be. The PEEK polymer has become a household name in orthopaedic implants and now MedShape is offering devices with the combined advantages of PEEK and a porous structure to encourage tissue ingrowth.